Short Term Efficacy and Safety of Vaginal CO2 Laser in Patients with Urodynamic Stress Urinary Incontinence

Alcalay M1, Ben Ami M2, Greenshpun A2, Shif E3

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 278
Female Incontinence
Scientific Podium Short Oral Session 16
Thursday 30th August 2018
09:20 - 09:27
Hall C
Stress Urinary Incontinence New Instrumentation Female Clinical Trial
1. Urogynecology Unit, Chaim Sheba and Poria Medical Centers, 2. Department of Ob Gyn, Poria Medical Center, 3. Department of Ob Gyn, Sheba Medical Center
Presenter
M

Menachem Alcalay

Links

Abstract

Hypothesis / aims of study
Urinary stress incontinence (USI) is a common complaint among women, with an observed prevalence between 4% and 35% (1). The severity of the incontinence varies, and urodynamic stress incontinence is the gold standard of this condition, defined as a finding of involuntary leakage during filling cystometry, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. 
The treatment of USI ranges from conservative treatment with pelvic floor exercises to surgical treatment, such as mid-urethral tapes or retro-pubic procedures. Although the outcome of the surgical procedures are well defined (2), most of the patients are reluctant to undergo surgical intervention to improve their quality of life and are looking for non-surgical options for treatment. 
Vaginal laser has recently been introduced as an optional treatment for urinary stress incontinence. The limited studies that were published are lack of urodynamic assessment, and most of them demonstrated significant subjective improvement (3). The objective of this study was to assess the efficacy and safety of vaginal CO2 laser in women with urodynamic stress incontinence.
Study design, materials and methods
This was a prospective multicenter study. The study protocol was approved by Helsinki committee in each institution, and every patient approved the study protocol by signing informed consent. Patients were eligible to participate if their main urinary incontinence complain was related to stress, had urodynamic stress incontinence and their severity of incontinence was graded as mild or moderate (by Sandvik score). Volunteers were excluded if they had previous anti incontinence surgery, if they had pelvic organ prolapse more than grade 2, or if their BMI was greater than 38. Five patients were excluded during urodynamic assessment due to lack of demonstration of stress incontinence. We used Femilift  (Alma Laser, ISRAEL) for vaginal application of pixelated CO2 laser. Every patient had three sessions of vaginal laser treatment through the hole vagina without anesthesia, 4-5 weeks apart, and follow up at 3, 6 and 12 months since treatment began. We used 1-hour pad test (ICS protocol), questionnaires including PFDI-20, PFIQ, Patient Global Impression of Improvement (PGI-I) and a 3-day urinary diary. We present an interim analysis at 3 months follow-up.
Results
We recruited 22 female patients with urodynamic proven stress incontinence, that completed follow-up for 3 months. Urodynamic assessment showed stable detrusor without voiding problem in all patients. The stress related leak was demonstrated either during coughs (mean CLPP=146.9) or Valsalva (mean VLPP=123.2). The patients’ mean age was 52.5 (range: 35-73), 36.4% were menopausal, parity was 2.6 (0-4), 13.6% were smoking and their mean BMI was 27.9 (18.4-37.2). No serious adverse events were recorded. Minor side effects that were related to treatment included: transient vaginal secretion (4 patients), vaginal irritation (1 patients), transient fever (1 patient), and UTI (1 patient).  The patients’ 1 hour pad test, number of incontinence episodes, number of pads used and PGI-I are shown in table 1. Pad test showed significant weight reduction, while 81.8% had pad test lower than 2 gr.  81.8% (18 of 22) of the patients felt improvement at 3 month following the treatment, and 54.5% (12 0f 22) defined it as a significant improvement. Reduction in the number of incontinence episodes and the number of pads used during follow-up did not reach significance. The monthly subjective global improvement is shown in Figure 1.
Interpretation of results
This is the first study for assessment of vaginal CO2 laser for patients with urodynamic stress incontinence. The interim results is based on subjective and objective outcome measures, and give us a wide range of patient acceptance of the treatment. The results of this study will enable us to evaluate this treatment option as an adjunct conservative treatment  for urinary stress incontinence.
Concluding message
Vaginal CO2 laser was found a safe treatment for patients with urodynamic proven stress incontinence. Significant objective and subjective improvement were time dependent and 81.8% reported improvement at 3-month follow-up. The short-term efficacy is promising, however, long term follow-up is needed.
Figure 1
Figure 2
References
  1. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S3-9.
  2. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010; 362:2066.
  3. González Isaza P, Jaguszewska K, Cardona JL, Lukaszuk I. Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 2018 Feb;29(2):211-215.
Disclosures
<span class="text-strong">Funding</span> The study was funded by Alma lasser <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Public Registry</span> No <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Sheba Medical Center and Poria Medical Center Ethical Commities <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes